Effect of Food on Pharmacokinetics of Obeticholic Acid (OCA)

NCT01914562 ↗

Phase 1 Completed 32 enrolled Intercept Pharmaceuticals

RandomizedCrossoverOpen-labelBasic science

Summary

This is an open label, randomized, balanced, single center, single dose, trial to assess the pharmacokinetic (PK) profile of OCA, glyco-OCA and tauro-OCA on an empty stomach (fasted condition) and following a high fat, high calorie meal (fed condition) in a 2-period, 2-sequence, crossover manner.

Timeline

Start: 2013-08
Primary completion: 2013-11
Completion: 2013-11

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	OCA	Unknown	10 mg	Oral
Subject	OCA	Unknown	25 mg	Oral

Indications

No indication recorded.